Follow-up Study for Participants of Jointstem Phase 3 Clinical Trial

Phase 3

Active, not recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Biological: JOINTSTEM

• Registration Number: NCT04427930
• Lead Sponsor: R-Bio

Brief Summary

The purpose of this follow-up study is to investigate the efficacy and safety of autologous Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee Osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-13
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-10
• Primary Completion: 2026-12-23
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Participants of Jointstem Phase 3 Clinical Trial
• Participates who signed informed consent document of this study

Exclusion Criteria

• No applicable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JOINTSTEM	JOINTSTEM	Long Term Follow-up after Jointstem Transplantation

Primary Outcome Measures

Name	Time	Method
Adverse Events	5 Years	Incidence of adverse events from baseline to 5 Years

Secondary Outcome Measures

Name	Time	Method
WOMAC 3 subscale score	5 Years	Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
SF-36	5 Years	The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
MRI scan	1, 2, 3, 4, 5 Years	The cartilage defect area is measured using MRI
Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline	5 Years	Pain, stiffness, and physical function of the knee will be measured by the WOMAC score
Measuring of Kellgren-Lawrence grade	1, 2, 3, 4, 5 Years	Measuring of Kellgren-Lawrence grade through X-ray
Measuring of Femoro-tibial anatomical angle(FTA)	1, 2, 3, 4, 5 Years	Measuring of FTA through X-ray
Measuring of Hip-Knee-Ankle angle(HKA)	1, 2, 3, 4, 5 Years	Measureing of HKA through X-ray
Measuring of Joint Space Width	1, 2, 3, 4, 5 Years	measuring Joint Space Width through X-ray

Trial Locations

Locations (4)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

KyungHee University Gangdong Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul ST. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of